# K193210: Hyper DLR

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Aug 4, 2020 after 257 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K002715 (2000). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172143: uMI 780 PET/CT System, Shanghai United Imaging Healthcare Co., Ltd. (2018) Summary page 4.
- K182237: uMI 550 PET/CT System, Shanghai United Imaging Healthcare Co., Ltd. (2018) Summary page 4.

## Indications for use
HYPER DLR is an image processing function intended to be used by radiologists and nuclear medicine physicians to reduce noise of the fluorodeoxyglucose (FDG) PET images.

Source page: https://510kreport.com/device/K193210
Methodology: https://510kreport.com/methodology